Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)

Completed

• Conditions: Knee Osteoarthritis; Knee; Total Knee Arthroplasty
• Interventions: Device: Triathlon PS TKA; Device: Persona PCR TKA; Device: Persona PS TKA; Device: Triathlon PCR TKA

• Registration Number: NCT04321356
• Lead Sponsor: The University of Tennessee, Knoxville

Brief Summary

The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who were implanted with Stryker Posterior Cruciate Retaining (PCR) , Stryker Posterior Stabilized (PS), Zimmer PCR, and Zimmer PS Total Knee Arthroplasty (TKAs). Our lab has previously collected data for the Smith \& Nephew PCR, bi-cruciate retaining (BCR), and bi-cruciate stabilized (BCS) TKA.

Detailed Description

The objective for this study is to analyze the in vivo kinematics for subjects implanted with either a Stryker PCR, Stryker PS, Zimmer PCR, and Zimmer PS TKA and to compare those patterns to subjects having a normal knee from our previous study and to those patterns from subjects having a Smith \& Nephew PCR, BCR, and BCS TKA.

Study Timeline

• Study First Submitted: 2019-12-19
• Study Start: 2020-02-24
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Results First Submitted: 2022-05-16
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Results First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Subjects will have one of the following implant types: 1) Stryker Triathlon PCR TKA (28 subjects), 2) Stryker Triathlon PS TKA (28 subjects), 3) Zimmer Persona PCR TKA (28 subjects) and 4) Zimmer Persona PS TKA (28 subjects).
2. Patients must be at least three months post-operative.
3. Participants must not experience any pain or other post-operative complications.
4. Participants must have a stable TKA and be capable of performing a deep knee bend activity.
5. Participants must weigh less than 300 lbs., not underweight (BMI < 18.5) or too obese (BMI>35).
6. Must be in the age range of 18 years to 85 years (both inclusive).
7. Participants must be able to perform the required activities without concern.
8. Subjects must be willing to sign the Informed Consent (IC) form to participate in the study.
9. Patients who do not have previous surgery on the implanted knee that might restrict their movement.

Exclusion Criteria

1. Pregnant, potentially pregnant, lactating females or of childbearing age. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study. (All potential female study patients will be asked if they are premenopausal or if they have undergone a hysterectomy. If the possibility of pregnancy exists, a pregnancy kit will be given to the patient at the informed consent meeting, just prior to the fluoro. Results of the test will be recorded in a test log. Any female patient showing a positive test will be excluded from testing.)
2. Subjects without the required type of knee implant.
3. Cannot have pain in other parts of the body that would prohibit the subject from performing the activities).
4. Cannot have ligamentous pain and/or laxity.
5. Unwilling to sign IC/HIPAA form(s).
6. Does not speak English.
7. Patients who have enrolled in a fluoroscopic kinematic study within the past year.
8. Patients currently involved in any personal injury litigation, medical/legal or worker's compensation claims.
9. Patients with known drug or alcohol abuse histories or psychological disorders that could affect ability to complete all aspects of the study.
10. Patients with neurological or musculoskeletal disorders that might adversely affect weight-bearing motion ability.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stryker Triathlon PS TKA	Triathlon PS TKA	Subjects implanted with a Stryker Triathlon PS TKA
Zimmer Persona PCR TKA	Persona PCR TKA	Subjects implanted with a Zimmer Persona PCR TKA
Zimmer Persona PS TKA	Persona PS TKA	Subjects implanted with a Zimmer Persona PS TKA
Stryker Triathlon PCR TKA	Triathlon PCR TKA	Subjects implanted with a Stryker Triathlon PCR TKA

Primary Outcome Measures

Name	Time	Method
Medial AP Translations, in mm, During Deep Knee Bend (DKB) Activity	3 months post-operative	Anterior Posterior (AP) translations, in mm, of medial femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the medial femoral condyle, and negative values indicate posterior motion of the medial femoral condyle.
Lateral AP Translations, in mm, During Deep Knee Bend (DKB) Activity	3 months post-operative	Anterior Posterior (AP) translations, in mm, of lateral femoral condyle during deep knee bend activity. Positive values indicate anterior motion of the lateral femoral condyle, and negative values indicate posterior motion of the lateral femoral condyle.
Maximum Flexion, in Degrees, During Deep Knee Bend Activity	3 months post-operative	Maximum weight-bearing flexion, in degrees, during deep knee bend activity
Axial Rotation, in Degrees, During Deep Knee Bend Activity	3 months post-operative	Axial rotation (AR), in degrees, during deep knee bend activity. Positive values indicate external femorotibial axial rotation, and negative values indicate internal femorotibial axial rotation.

Trial Locations

Locations (2)

The University of Tennessee; 🇺🇸 Knoxville, Tennessee, United States

Tennessee Orthopaedic Clinic; 🇺🇸 Knoxville, Tennessee, United States